Skip to main content
OpenTrials
Completed

NCT Number: NCT05153551

Pediatric Early Autism Recognition System: PEARS

The goal of the study is to assess a new autism evaluation model that would include the addition of a Level-2 autism screener, the Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), to the developmental screening already done by the child's pediatrician.

The study hypotheses:

1. The PEARS intervention will show high feasibility to primary care physicians (PCPs) and patient families. 2. The PEARS intervention will lead to increased parent activation around autism diagnosis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Disease Mental Disorders Neurodevelopmental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Medicine Briarwood Center for Women, Children, and Young Adults., Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Child:

  • Increased risk for Autism Spectrum Disorder (ASD) defined as:
  • positive Modified Checklist for Autism in Toddlers-Revised (MCHAT) (score greater than 3);
  • OR having a sibling or parent with ASD;
  • OR history of prematurity (gestational age less or equal 34 weeks);
  • OR other provider or parent concern for ASD.
  • Child age 18-36 months

Exclusion criteria

- Child:

  • previous ASD diagnosis
  • previous negative ASD evaluation
  • known seizure disorder
  • vision impairment
  • hearing impairment

Inclusion criteria

- Parent

  • Parent or legal guardian of the children

Exclusion criteria

- Parent

  • Not a Parent or legal guardian of the child

Treatment and study plan

Play-based assessment (RITA-T)

Other

The RITA-T is a play-based assessment that involves nine different activities that can be done safely with a child seated in the exam room. After scoring the RITA-T, the PEARS PCP will immediately provide feedback to the parent regarding results and next steps.

In addition, parents will complete certain assessments/surveys during the study to evaluate the program.

Primary outcomes

  1. Proportion of PEARS PCP visits in which PCPs report overall feasibility in regard to workflow, delivery, and administration of the RITA-T

    Time frame: Approximately day 7 (Time 3)

    This is based on a 6 question feasibility survey (score of 24 or greater would be considered feasible).

  2. Percentage of parents that felt that the RITA-T visit was comfortable and useful

    Time frame: Approximately day 35 (time 5)

    This is based on a 5 question feasibility survey (score of 20 or greater would be considered feasible).

  3. Change on the Parent Activation Measure for Children with Developmental Disabilities (PAM-DD)

    Time frame: Baseline(day 1), approximately day 35 (time 5)

    Items are scored using a 4-point a Likert-type scale (1 = disagree strongly to 4 = agree strongly). Raw scores are summed and scaled from 0 to 100 using weighted scores based on Guttman scaling. Higher scores correspond to higher activation. This 13-item measure will be administered verbally to parents at baseline and 3-4 weeks post-RITA-T assessment. Changes from baseline to follow-up will be calculated for each participant.

  4. Qualitative data from parents semi-structured interviews

    Time frame: Approximately day 35 (time 5)

    The study team will analyze transcripts of parent semi-structured interviews to assess general sense of empowerment and motivation, with a focus on novel insights into the experience of parents of children undergoing a Level-2 screening instrument within the medical home.

Secondary outcomes

  1. The number of days between enrollment and completed RITA-T assessment

    Time frame: Approximately 7-14 days

  2. The percentage of participants that experienced scheduling and/or transportation barriers

    Time frame: Approximately day 35 (time 5)

    This data will be collected by the research assistants or reported by parents during the follow-up semi-structured interview.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Blue Cross Blue Shield of Michigan Foundation

Registry information

Acronym: PEARS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.